基于新型冠状病毒肺炎疫情中药新药注册的思考

Thoughts on the registration of new traditional Chinese medicines in the COVID-19 epidemic situation

中医药在此次新型冠状病毒肺炎(以下称新冠肺炎)疫情的防治中发挥了重要作用。在疫情严峻、救治优先的背景下,新冠肺炎的临床研究是分阶段分层次进行的,因此应以发展的眼光看待中药临床研究定位随着临床治疗的深入不断深入,体现基于临床价值的时效性;同时以发展的眼光看待新冠肺炎临床研究及取得的临床研究证据,利用好这些研究成果。本文结合国家陆续出台的一系列新药注册审评政策,从用于注册审评证据、中药人用经验证据、古代经典名方制剂的审批、证候药的研发和中药网络药理学的应用等方面,探讨了新发突发重大传染病中药新药注册审评的思考。

Traditional Chinese medicine has played an important role in the prevention and control of epidemic of novel coronavirus pneumonia(NCP).In the context of severe epidemic situation and priority in treatment,clinical research on NCP is carried out in stages and at different levels.Therefore,TCM clinical research positioning should be viewed from the perspective of development.At the same time,it is supposed to take a developmental view of the clinical research and the clinical research evidence obtained on NCP and make good use of these research findings.Combining with a series of new drug registration review policies issued by the State,this paper proposed some considerations on the registration review of new drugs for emerging major infectious diseases from the aspects of registration review evidence,empirical evidence for human use of traditional Chinese medicine,approval of ancient famous prescriptions,research and development of drugs for syndromes,and application of traditional Chinese medicine network pharmacology.